Chris Reid is CEO of the Integrity Solutions group of companies. Chris started his career as an automation engineer, providing software solutions to the chemical and pharmaceutical industry. For the past 25+ years, Chris has provided IT program governance and IT quality solutions to global regulated companies. Chris is a former ISPE Board Member, ISPE GAMP Global Chair and currently holds positions on the ISPE Foundation Board and GAMP Global Steering Committee.
This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiativeUS Food and Drug Administration Center for Devices...
In the previous blog, GAMP® Support for Pragramtic Quality & Risk-Based Approaches, we saw how as part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) are promoting a risk-based, product quality and...
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management...